Job Title: Project Engineer I
- The Project Engineer I position is an entry level position within the Corporate Engineering Department with the primary responsibilities of assisting with the execution of Corporate Engineering equipment, building and facilities projects. The Project Engineer I reports to the Director Corporate Engineering. The Project Engineer I will assist with the execution of projects to design, construct and qualify all Lannett buildings and facilities, including renovations of existing buildings for all Lannett Oral Solid Dosage Pharmaceutical and Oral Solutions Pharmaceutical manufacturing / packaging and R&D facilities. The Project Engineer I will assist with equipment installation projects and will conduct equipment qualifications. The Project Engineer I will assist with developing and maintaining Lannett engineering standards for the design of buildings and operations.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Creates and updates project schedules and budgets to achieve Lannett goals and objectives
- Assists with projects involving new technologies, to support faster and lower cost solutions in manufacturing, processing, packaging, and plant utilities.
- Assists with projects in the Oral Solid Dosage and Oral Solutions manufacturing, processing and packaging areas, including new facilities and flexible manufacturing / packaging solutions within existing sites.
- Provides reports on the status of project milestones and adjusts project schedules accordingly.
- Maintains records to assure that labor and material expenditures remain within the limitations of the project budget.
- Supports the development and review of project deliverables, capital budgets, design documents, bid packages and submittals from third party firms.
- Assists with projects for new equipment installation and renovation of manufacturing equipment, process equipment and packaging equipment.
- Assists with projects for new equipment installation and renovation of plant utilities including HVAC, purified water, compressed air, plant steam, heat transfer systems, plumbing and electrical systems.
- Assists with the preparation of User Requirement Specifications, Functional Requirements Specifications, Design Specifications, IQ protocols, OQ protocols, PQ protocols, Commissioning plans, Architectural drawings, Mechanical drawings, Electrical drawings and Piping & Instrumentation Diagrams (P&ID’s).
- Assists with the execution of approved IQ, OQ and PQ qualification protocols with contractors for given projects.
- Assists with the summary and analysis of IQ, OQ, PQ and Commissioning data including testing and monitoring results for the preparation of summary reports.
- Assists with the request for proposals, bid evaluation / leveling and contract negotiations for new projects
- Supports maintaining conformance with engineering standards for given projects.
- Supports the evaluation of new potential plant sites and third party equipment proposals to ensure the best fit between user requirements and technology.
- Supports maintaining project conformance with Lannett Environmental, Health & Safety (EHS) initiatives including industrial hygiene, safety, security and environmental programs leading towards a safe and accident-free environment.
- Participates in facility inspections and audits to detect existing or potential GMP and EHS issues.
- Makes recommendations to improve the Engineering procedures related to building systems and plant utilities.
- Supports all aspects of process change control (evaluation, approval, communication, planning, scheduling, qualification, project documentation, auditing, training and implementation).
- Assists with Factory Acceptance Test (FAT) teams at vendor sites
- Writes other reports and correspondence as required.
QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Knowledgeable with current Good Manufacturing Practices (cGMP’s) as per ICH Q7, Q8, Q9, Q10 and Q11 as well as 21 CFR Parts 210 and 211
EDUCATION and/or EXPERIENCE
- Bachelor Degree in Engineering (Chemical, Mechanical, Packaging or Pharmaceutical)
- Able to review Algebraic, Geometric and Statistical calculations for data analysis.
- Able to use MS Word, MS Excel, MS Outlook, MS Project, MS Visio and AutoCAD for report preparation, data analysis, interoffice communication and project schedule development
- Able to analyze Engineering issues and propose resolutions
CERTIFICATES, LICENSES, REGISTRATIONS
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Able to wear personal protective equipment (PPE) for safety in the manufacturing areas
- Able to travel between Lannett sites and attend off-site meetings as necessary
- Able to travel to Contractor and Vendor sites as necessary
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Works primarily with the Lannett staff members, Corporate Engineering department employees and contractors as appropriate